# K043239: Healthstar Elite

- Pathway: 510(k) (Traditional)
- Applicant: Hill Laboratories Co.
- Decided: Dec 22, 2004 after 29 days
- Product code: ITH (Equipment, Traction, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K894435 (1989). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981822: DRS System, Professional Distribution Systems, Inc. (1998) Summary page 1.
- K030060: Spinemed, Cert Health Sciences, LLC (2003) Summary page 1.
- K002260: Spina System, North American Medical Corporation (Nam) (2000) Summary page 2.

## Indications for use
The Healthstar Elite machine administers genuine intervertebral decompression. Each treatment session consists of a physician prescribed treatment period on the Healthstar Elite. A treatment is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. The machine can be used to relieve sciatica pain and pain associated with: bulging or herniated discs, degenerative disc disease, and posterior facet syndrome. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning. This device is for prescription use only.

Source page: https://510kreport.com/device/K043239
Methodology: https://510kreport.com/methodology